S0212 Celecoxib in Treating Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix

This study has been withdrawn prior to enrollment.
(drug issues)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
First received: November 4, 2003
Last updated: November 7, 2013
Last verified: November 2013

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. Celecoxib may be effective in preventing cervical cancer.

PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing cervical cancer in patients who have high-grade squamous intraepithelial lesions of the cervix.

Condition Intervention Phase
Stage 0 Cervical Cancer
High-grade Squamous Intraepithelial Lesion
Drug: celecoxib
Procedure: anti-cytokine therapy
Procedure: antiangiogenesis therapy
Procedure: biological therapy
Procedure: cancer prevention intervention
Procedure: chemoprevention of cancer
Procedure: enzyme inhibitor therapy
Procedure: growth factor antagonist therapy
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: S0212: Phase IIb Randomized Study of Celecoxib in Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix

Resource links provided by NLM:

Further study details as provided by Southwest Oncology Group:

Enrollment: 0
Detailed Description:


  • Compare the complete response rate in patients with high-grade squamous intraepithelial lesions of the cervix treated with celecoxib vs placebo.
  • Compare the toxicity of these drugs in these patients.
  • Determine, preliminarily, the effect of celecoxib on cyclooxygenase-2 expression and human papilloma virus expression in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to high-grade squamous intraepithelial lesion status (cervical intraepithelial neoplasia [CIN] 2 vs CIN 3). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral celecoxib twice daily for 1 month.
  • Arm II: Patients receive oral placebo twice daily for 1 month. In both arms, treatment repeats monthly for 3 courses in the absence of disease progression or unacceptable toxicity. All patients then undergo loop electrosurgical excision procedure or cone biopsy to determine response.

PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study within 1-2 years.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Histologically confirmed high-grade squamous intraepithelial lesions (HGSIL) of the cervix
  • Cervical intraepithelial neoplasia (CIN) 2 (moderate dysplasia) OR CIN 3 (severe dysplasia, carcinoma in situ)
  • Must have remaining HGSIL after biopsy
  • No suspicion of invasive cancer by colposcopy within the past 28 days
  • No invasive or preinvasive high-grade intraepithelial neoplasia by endocervical curettage within the past 56 days



  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified


  • Not specified


  • SGOT and SGPT less than 2.0 times upper limit of normal (ULN)
  • Bilirubin less than 2.0 times ULN


  • Creatinine less than 2.0 mg/dL


  • No prior asthma, urticaria, or allergic-type reactions to aspirin or other NSAIDs
  • No allergy to sulfonamides
  • No known sensitivity to celecoxib
  • No known AIDS or HIV-associated complex


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated stage I or II cancer currently in complete remission


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • No prior pelvic radiotherapy


  • See Disease Characteristics


  • More than 3 months since prior topical medications for genital condyloma
  • No prior treatment for squamous intraepithelial lesions
  • No concurrent topical medications for genital condyloma
  • No other concurrent treatment
  • No concurrent chronic (daily for more than 30 days) aspirin
  • No other concurrent nonsteroidal anti-inflammatory drugs (NSAIDs)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00072540

Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: William R. Robinson, MD Harrington Cancer Center
  More Information

No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00072540     History of Changes
Other Study ID Numbers: CDR0000340176, S0212, U10CA037429
Study First Received: November 4, 2003
Last Updated: November 7, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Additional relevant MeSH terms:
Cervical Intraepithelial Neoplasia
Uterine Cervical Neoplasms
Carcinoma in Situ
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms
Enzyme Inhibitors
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2015